MRL in the Upper Extremity

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Lymphedema of Upper Limb

Treatments: Diagnostic Test: Magnetic Resonance Lymphography

Study type: Interventional

Funder types: Other

Identifiers

NCT04575636

NL72424.068.19

Details and patient eligibility

About

Objective: The aim of this study is to examine the feasibility and applicability of the MRL protocol for the upper extremity in Maastricht University Medical Center, and to examine the differences of the lymphatic system between lymphedema patients and healthy volunteers.

Study design: An explorative study of an MRL protocol for the upper extremity in Maastricht University Medical Center+.

Study population: There are two study groups. The first group (n=10) consists of patients with secondary lymphedema in the upper extremity. The second group (n=10) consists of healthy volunteers.

Intervention (if applicable):

All participants will undergo an MRL examination with the same protocol, developed in a previous 'proof of principle' study, in the Maastricht University Medical Center+.

After localizer scans, a T2-weighted sequence is used. Then a T1-weighted sequence will be made before the injection of contrast. After the injection of the contrast agent a T1-weighted sequences of the upper and lower arm are performed alternately.

Main study parameters/endpoints:

The primary outcome is to determine the feasibility and applicability of the MRL protocol by evaluating the images of the upper extremity in patients with secondary lymphedema and healthy subjects.

The secondary outcome is to assess the value of MRL in staging lymphedema.

Enrollment: 20 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older
• informed consent
• BMI < 30 kg/m2

Group A:

• Secondary lymphedema in the upper extremity

Group B:

• Healthy volunteers

Exclusion criteria

• Active skin infection/erysipelas in the arm.
• Known allergy for a contrast agent
• History of surgical intervention in the arm.
• Contraindications for MRI with contrast; pregnancy, metals, prostheses, renal insufficiency, claustrophobia
• Active cancer
• Distant metastases

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Lymphedema patients

Other group

Description:

MRL examination in lymphedema patients

Treatment:

Diagnostic Test: Magnetic Resonance Lymphography

Healthy volunteers

Other group

Description:

MRL examination in healthy volunteers

Treatment:

Diagnostic Test: Magnetic Resonance Lymphography